|- candidate number||16121|
|- NTR Number||NTR4405|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jan-2014|
|- Secondary IDs||NL45594.091.13 Commissie Mensgebonden Onderzoek regio Arnhem – Nijmegen (UMC St Radboud)|
|- Public Title||ChIP-Studie: Changing Interpretations in PTSD|
|- Scientific Title||Cognitive Bias Modification in Posttraumatic Stress Disorder: Training Positive Appraisal Style. |
|- ACRONYM||ChIP (Changing Interpretations in PTSD)|
|- hypothesis||We hypothesize that an appraisal- specific, computerized CBM training (referred to as CBM-app) can induce positive appraisal styles in a sample of PTSD patients. We expect that, compared to participants who receive a neutral training, those who receive positive CBM-app training will show less PTSD related dysfunctional cognitions/symptoms post training.
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD)|
|- Inclusion criteria||1. Between 18 en 70 years of age
2. Diagnosis of PTSD (structured interview MINI)
3. Self reported PTSD symptoms (PSS-SR > 20)
4. History of interpersonal trauma
5. Internet access and desktop computer
|- Exclusion criteria||1. Psychosis or delusion disorders (current/past)
3. Mental retardation
4. Substance/alcohol abuse or dependence
5. Insufficient ability to speak and write Dutch
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-feb-2014|
|- planned closingdate||31-dec-2015|
|- Target number of participants||146|
|- Interventions||Interpretation bias modification (CBM-app):
This training comprises processing a series of reappraisal-related scripted vignettes (40 sentences per training session, 4 training sessions in total) that appear to participants as a sentence completion task. Each sentence comprises one to-be-completed word fragment, such that the meaning of the sentence remains ambiguous until the final word fragment is resolved.
Positive training group:
The word fragments produce an outcome consistent with positive (re) appraisal by assigning a positive meaning to the sentence.
Neutral training group:
The word fragments produce an outcome consistent with ambiguous (re) appraisal, as the meaning of the sentence will remain ambiguous.
|- Primary outcome||1.
Appraisal Index (pre to post training). The “Appraisal Index” measures positive interpretation style in PTSD patients. It is calculated by summing up the number of PTSD-related appraisals in response to an open-ended ambiguous sentence task. A higher score on this “Appraisal Index” represents a more dysfunctional, PTSD-related interpretation style.
Post Traumatic Cognition Inventory (PTCI, pre to post training).
|- Secondary outcome||1.
Interpretation bias as assessed with the Word Sentence Association Paradigm (WSAP).
Posttraumatic Stress Symptom Scale, Self Report (PSS-SR) (Foa, et al., 1993).
Frequency and amount of distress provoked by the most important, trauma-related re-experience in the preceding week
Negative Life Events and Trauma Questionnaire (NLETQ).
Health Status as measured with EuroQol (EQ-5d).
Depression as measured by Beck Depression Inventory (BDI).
Symptoms of borderline personality disorder, as measured by the Borderline Personality Disorder Checklist (BPD).
Self-compassion as measured by a short-form version of the Self-Compassion Scale Short Form (SCS-SF)
Explicit self-esteem, as assessed with the Rosenberg Self-Esteem Scale (RSES)
Implicit self-esteem as assessed with an Implicit Association Test (IAT).
Implicit trauma-identification as assessed with an Implicit Association Test (IAT).
The development of "Appraisal Index" and "Frequency/amount of distress of most important re-experience": Assessment before/after each training session.
The influence of CBM-app training on course of PTSD over a six months follow-up period.
Success of treatment as usual following the study.
|- Timepoints||Primary outcome measures:
1. Appraisal Index (pre to post training).
2. PTCI (pre to post training).
Secondary outcome measures:
1. WSAP (pre to post).
2. PSS-SR (pre to post).
3. Frequency/Distress re-experience (pre to post).
4. Trauma characteristics (pre).
5. Trauma-related psychopathology (pre to post).
6. Personality (pre).
7. Implicit measures (pre).
8. Development of Appraisal Index (before and
after each training session). Development of
Frequency/ amount of distress of most
important re-experience (before each training
9. Outcomes on 1 month and 6 month follow up:
Appraisal Index, PTCI, PSS-SR,
10. Success of treatment as usual (follow up)|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Rianne Kleine, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr A. Minnen, van|
|- Sponsor/Initiator ||ProPersona/Overwaal|
(Source(s) of Monetary or Material Support)
|- Brief summary||In this randomized clinical trial, we want to examine whether a CBM training aimed at inducing positive appraisal style (positive CBM-app) can alter dysfunctional appraisal styles in PTSD patients. We will investigate the effects of CBM-app training on PTSD related dysfunctional cognitions and PTSD symptoms.
Country of Recruitment: The Netherlands|
|- Main changes (audit trail)|
|- RECORD||21-jan-2014 - 3-nov-2016|